Standard: AAMI 14708-5
IMPLANTS FOR SURGERY — ACTIVE IMPLANTABLE MEDICAL DEVICES — PART 5: CIRCULATORY SUPPORT DEVICES
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This part of ISO 14708 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps.
This part of ISO 14708 specifies type tests, animal studies and clinical evaluation requirements.
NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami 14708-5|
|Most Recent Revision:||YES|